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Osphena

(Ospemifene)

ApprovedSmall molecule

DDuchesnay Inc.

Osphena is one of 66 small molecule programs targeting Dyspareunia. It is currently in Approved.

3

Indications

10

Total Trials

0

Active Trials

65

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

2

Patents

Pipeline

Status by Indication[3][1]

Indication

DyspareuniaActive, not recruiting

Sexual DysfunctionActive, not recruiting

AtrophyActive, not recruiting

DyspareuniaApproved

Active, not recruiting

Sexual DysfunctionApproved

Active, not recruiting

AtrophyPhase 2

Active, not recruiting

Competition

Competitive Landscape

72 competitors in Atrophy

#DrugCompanyPhaseTrials

Evrysdi

Actos

Activella

Intrarosa

Alnylam Pharmaceuticals

Osphena

DDuchesnay Inc.

Pitocin

Avandia

Alnylam Pharmaceuticals

Protease Inhibitor

MMedical Research Council

Avodart

Akero Therapeutics

Genotropin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Atrophy4 trials

A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women

Completed· Shionogi logo

Shionogi·Phase 3·NCT00276094·826 enrolled

Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Completed· Shionogi logo

Shionogi·Phase 3·NCT01586364·301 enrolled

Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus

Completed· Shionogi logo

Shionogi·Phase 3·NCT01585558·180 enrolled

Show 1 more trial

A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women

Completed· Shionogi logo

Shionogi·Phase 2·NCT00630539·126 enrolled

Menopause1 trial

Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause

Completed· Shionogi logo

Shionogi·Phase 3·NCT02638337·631 enrolled

Dyspareunia1 trial

Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA

Completed·SSue Goldstein·Phase 4·NCT02784613·10 enrolled

Sexual Dysfunction1 trial

Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction

Terminated·EEmory University·Phase 4·NCT03018106·1 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity

Completed· Shionogi logo

Shionogi·Phase 3·NCT00729469·919 enrolled

2 more indications

Women1 trial

Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders

Completed·HHospital Clinic of Barcelona·Phase 4·NCT04677491·25 enrolled

Unspecified1 trial

A Clinical Study to Evaluate the Safety of Ospemifene

Completed· Shionogi logo

Shionogi·Phase 3·NCT00566982·426 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 26, 2013

OSPHENA

NDA NDA203505

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Ospemifene. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ospemifene compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ospemifene. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA203505). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Osphena. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Duchesnay Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: DDuchesnay Inc.

Patent Landscape[5]

Patent Cliff

Aug 11, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8236861Aug 11, 2026

8642079Jul 9, 2028

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